DEVELOPMENT AND VALIDATION OF RP- HPLC METHOD FOR DETERMINATION OF CITICOLINE MONOSODIUM IN PHARMACEUTICAL PREPARATIONS

A Simple, selective, rapid, precise and economical reverse phase HPLC method was developed and validated for the Quantitative Estimation of Citicoline Monosodium in pharmaceutical preparation. Isocratic separation was accomplished using C18 column (250 mn x 4.6 mm, 5 μm particle size) with mobile phase consisting of Tbahs Buffer (pH 6): Methanol (95:05, v/v), flow rate was 1.0 ml/min. and the detection wavelength was 270 nm. The proposed method has permitted the quantification of Citicoline Monosodium in the linearity range of 20- 100 μg/ml with coefficient of correlation (r2) 0.9999.The column was maintained at ambient temperature and analytical run time of approximately 10 min and it was eluting at approximately 6.3±0.5 min.The percentage recovery was found to be in between 97.85-99.75 % and the % RSD of system and method precision was found to be 0.187±0.18. The percentage amount of marketed formulation of Citicoline Monosodium was found to be 99.54 %. The method was validated for linearity, accuracy, precision, specificity, Robustness, solution stability, the assay may be applied to a routine analysis in industries.